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临床试验/NCT07401446
NCT07401446已完成不适用

Comparison of Complication Rates of Onlay vs Sublay Mesh Repair of Incisional Hernia

Hayat Abad Medical Complex, Peshawar1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2020年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
350
试验地点
1
主要终点
Postoperative Complication Rate

研究概览

简要总结

This randomized controlled trial was conducted at the Department of Surgery, Hayatabad Medical Complex, Peshawar. Eligible patients with incisional hernia were randomized into two parallel groups: sublay mesh repair and onlay mesh repair. Procedures were performed by a single experienced general surgeon. Postoperative complications were assessed by an independent surgeon blinded to the type of procedure. Patients were followed for a period of three months to evaluate safety and recurrence outcomes.

详细描述

Incisional hernia is a frequent postoperative complication following abdominal surgery and represents a significant source of morbidity due to discomfort, impaired quality of life, and risk of recurrence. Mesh reinforcement has become the standard approach for incisional hernia repair; however, the optimal anatomical position of mesh placement remains debated. Among the commonly used techniques, onlay mesh repair involves placement of mesh over the anterior rectus sheath, while sublay mesh repair places the mesh in the retromuscular preperitoneal plane. Each technique differs in operative dissection, tissue handling, and potential risk of postoperative complications.

This randomized controlled trial was conducted at the Department of Surgery, Hayatabad Medical Complex, Peshawar, to compare postoperative outcomes of onlay versus sublay mesh repair in patients undergoing elective incisional hernia repair. Adult patients aged 18 to 60 years presenting with incisional hernia and meeting predefined eligibility criteria were enrolled after providing written informed consent. Patients with recurrent, strangulated, or obstructed hernias, severe comorbid conditions, high anesthetic risk, or morbid obesity were excluded to minimize confounding factors.

Eligible participants were randomly allocated into two parallel groups using a lottery method. Patients assigned to Group A underwent sublay mesh repair, while those in Group B received onlay mesh repair. All surgical procedures were performed by a single experienced general surgeon to ensure procedural consistency. Standardized perioperative care protocols were followed for all patients.

Postoperatively, patients were monitored during hospital admission and followed in outpatient clinics for a period of three months. Assessment of postoperative complications, including wound infection, seroma, hematoma, and hernia recurrence, was carried out by an independent surgeon who was blinded to the surgical technique used. This masking approach was adopted to reduce assessment bias.

The primary objective of the study was to compare the overall postoperative complication rates between the two mesh placement techniques. Secondary objectives included evaluation of individual complication rates and recurrence during the follow-up period. Data were collected using a structured proforma and analyzed using standard statistical methods to determine differences between groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

This was an open-label study. Due to the nature of the surgical interventions, neither participants nor healthcare providers nor outcome assessors were blinded to the assigned intervention.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-60 years.
  • Patients diagnosed with primary incisional hernia on clinical examination.
  • Hernia suitable for open surgical repair with mesh.
  • Both male and female patients.
  • Patients able and willing to provide written informed consent.

排除标准

  • Obstructed or strangulated hernia on presentation.
  • Recurrent incisional hernia.
  • Patients with BMI >
  • Patients with debilitating chronic diseases, including:
  • Chronic liver disease
  • Chronic renal impairment
  • Chronic cardiac disease
  • Chronic pulmonary disease
  • Patients with American Society of Anesthesiologists (ASA) physical status ≥
  • Patients unfit for general anesthesia.
  • Patients unable or unwilling to follow up for postoperative assessment.

研究组 & 干预措施

Sublay Mesh Repair

Experimental

Patients underwent open incisional hernia repair with placement of polypropylene mesh in the retromuscular preperitoneal (sublay) plane.

干预措施: Sublay Mesh Repair (Procedure)

Onlay Mesh Repair

Active Comparator

Patients underwent open incisional hernia repair with placement of polypropylene mesh over the anterior rectus sheath (onlay technique).

干预措施: Onlay Mesh Repair (Procedure)

结局指标

主要结局

Postoperative Complication Rate

时间窗: 30 days after surgery

Incidence of complications within 30 days after surgery, including wound infection, seroma, hematoma, and hernia recurrence, in patients undergoing onlay versus sublay mesh repair of incisional hernia.

次要结局

  • Length of Hospital Stay(Number of days From enrollment up to the hospital discharge)
  • Hernia Recurrence Rate(Assessed at 6 months and 12 months after surgery)
  • Operative Time(During the index surgical procedure (from skin incision to skin closure))

研究者

发起方
Hayat Abad Medical Complex, Peshawar
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gohar Ali

Principal Investigator

Hayat Abad Medical Complex, Peshawar

研究点 (1)

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